Research Article CAM and Pediatric Oncology: Where Are All ...downloads.hindawi.com/journals/ecam/2013/632351.pdf · and investigate exceptional cases or best cases in cancer patients

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2013, Article ID 632351, 6 pageshttp://dx.doi.org/10.1155/2013/632351

Research ArticleCAM and Pediatric Oncology: Where Are All the Best Cases?

Denise Adams,1 Courtney Spelliscy,2 Leka Sivakumar,2 Paul Grundy,3 Anne Leis,4

Susan Sencer,5 and Sunita Vohra6

1 CARE Program, Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton General Hospital,8B19-11111 Jasper Avenue, Edmonton, AB, Canada T5K 0L4

2 Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada T6G 2R33Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada T6G 2R34College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada S7N 5E55Hematology/Oncology, Children’s Hospitals and Clinics of Minnesota, 2525 Chicago Avenue, Minneapolis, MN 55404, USA6CARE Program, Department of Pediatrics, Faculty of Medicine & Dentistry and School of Public Health, University of Alberta,Edmonton General Hospital, 8B19-11111 Jasper Avenue, Edmonton, AB, Canada T5K 0L4

Correspondence should be addressed to Sunita Vohra; [email protected]

Received 5 June 2013; Accepted 24 June 2013

Academic Editor: Claudia M. Witt

Copyright © 2013 Denise Adams et al. This is an open access article distributed under the Creative Commons Attribution License,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background. Use of complementary and alternative medicine (CAM) by children with cancer is high; however, pediatric best casesare rare. Objectives. To investigate whether best cases exist in pediatric oncology using a three-phase approach and to compare ourmethods with other such programs.Methods. In phase I, Children’s Oncology Group (COG) oncologists were approached via emailand asked to recall patients who were (i) under 18 when diagnosed with cancer, (ii) diagnosed between 1990 and 2006, (iii) hadunexpectedly positive clinical outcome, and (iv) reported using CAMduring or after cancer treatment. Phase II involved partneringwith CAM research networks; patients whowere self-identified as best cases were asked to submit reports completed in conjunctionwith their oncologists. Phase III extended this partnership to 200 CAM associations and training organizations. Results. In phaseI, ten cases from three COG sites were submitted, and most involved use of traditional Chinese medicine to improve quality oflife. Phases II and III did not yield further cases. Conclusion. Identification of best cases has been suggested as an important stepin guiding CAM research. The CARE Best Case Series Program had limited success in identifying pediatric cases despite the threeapproaches we used.

1. Introduction

Complementary and alternative medicine (CAM) is popularin both adults and children [1].Within the pediatric oncologypopulation, CAMuse has been reported as high as 84% [2–5],most commonly used as an adjunct to conventional medicaltreatment [6]. Pediatric CAM use has been associated withpoor prognosis, as well as parental factors, such as their CAMuse, age, and education [2]. Reasons reported for use arevaried, such as to explore all possible treatment options [6];enhance the efficacy or minimize side effects of conventionaltherapy [7]; boost immunity [6]; cure the cancer or slow itsprogression [6, 7]; and increase feelings of control over thechild’s treatment [7]. Many patients describe CAM as beinghelpful, and few report adverse effects [6, 8].

Despite the popularity of CAM, only half of parentsdisclose their child’s CAM use to their physicians [3]. Lessthan half of pediatric oncologists inquire about CAMuse, dueto lack of time and knowledge or discomfort due to concernover harmful side effects [9]. The increased use of CAM inthis vulnerable population reinforces the need for researchinto safety and efficacy to allow for informed decisionmakingby physicians, patients, and families.

Several countries have developed initiatives to identifyand investigate “exceptional cases” or “best cases” in cancerpatients who use CAM [10]. One such program is hosted bythe United States National Cancer Institute (NCI). In 1991,the NCI initiated the “Best Case Series Program” to evaluatepotentially effective CAM therapies, with the goal of identi-fying those that warranted further research. In this program,

2 Evidence-Based Complementary and Alternative Medicine

cases are submitted by CAM practitioners to NCI who thenconducts rigorous reviews of the case medical records. NCIBest Case criteria are among themost rigorous of the existingprograms and include verification of a definitive diagnosis ofcancer, documentation of disease response, and absence ofconfounders including concurrent conventional treatmentsand well-documented treatment history [11]. To our knowl-edge, theNCI Best Case Series Program inspiredmost similarexisting programs. The NCI approach is recognized foryielding data with few confounders, while an acknowledgedlimitation is that exceptional results are framed only in termsof tumor regression, which does not take into considerationwhy oncology patients use CAM therapies.

Since NCI reported no pediatric best cases and sincemany children with cancer use CAM, we undertook a multi-step approach to see if pediatric best cases could be identified.While our Pediatric Best Case Series was based on the NCIBest Case Series Program, we deliberately relaxed some of thecriteria in order to be applicable to a pediatric population.Specifically, we allowed for concurrent use of CAM withconventionalmedical care, as it seemed unlikely that childrenwould be permitted to forego conventional cancer treatmentin favour of alternative therapies alone. Furthermore, weexpanded the definition of a “best case” to include outcomesof interest to patients and families, such as prolonged survivaland a markedly improved quality of life, as defined byrespondents. Finally, in contrast to the NCI approach forcase identification, we explored three different approachesto identify pediatric best cases in three steps: (i) throughoncologists; (ii) through CAM research networks; and (iii)through CAM associations and colleges.

2. Objectives

Our Pediatric Best Case Series had two main objectives: (i)to identify if “best cases” associated with CAM use existedin pediatric oncology and (ii) to compare the utility of threedifferent approaches to case identification (steps I, II, and III).

3. Methods

In step I, pediatric oncologists affiliated with the Children’sOncology Group (COG), including the 17 Canadian sites(C17), were contacted via email between January and Aprilof 2007. Oncologists were asked to recall patients who metthe following criteria: under 18 when diagnosed with cancer;diagnosed between 1990 and 2006; had, in their opinion,unexpectedly positive clinical outcome (as defined by tumorregression, prolonged survival, and/or improved quality oflife); and reported CAMuse during or after cancer treatment.

Step II of the project involved partnering with CAMresearch networks. In November 2007 and February 2008,seven Canadian and US CAM networks were asked toadvertise this study on their websites and list serves. CAMproviders who learned of the study through these advertise-ments were asked, in turn, to notify their cancer patients ofthis study. Patients who were self-identified as best cases wereasked to submit reports completed in conjunction with theironcologists.

Step III extended this partnership to include CAMassociations and training organizations in Canada andthe USA, representing the following modalities: acupunc-ture/acupressure, aromatherapy, art therapy, Ayurveda, chi-ropractic, herbalism, homeopathy, hypnotherapy, massage,music therapy, naturopathy, osteopathy, reflexology, reiki,therapeutic/healing touch, traditional Chinesemedicine, andyoga. In September 2008 and February 2009, email noticeswere sent to over 100 Canadian and 100USCAMassociationsand organizations asking them to advertise this study on theirwebsites and list serves. CAM providers and patients wereinvolved as for step II.

In order to identify similar programs around the world, asearch strategy was developed using the snowball approach.Electronic databases, including Medline and Embase, weresearched using the terms “Best Case Series” and “exceptionaldisease course”. References of identified articles were subse-quently screened for further information. Coordinators oradministrators of the identified programs were contactedthrough email for additional details regarding their pro-grams. Submitted cases were compiled descriptively.

4. Results

In step I, eleven cases from three COG sites were submitted.Two cases were excluded; one as it did not include a CAMtherapy, and the other because the patient was 19 whendiagnosed with cancer. The majority of the cases involvedthe use of traditional Chinese medicine (TCM) to improvequality of life (Table 1). Of note, seven cases were submittedby the CAM practitioner employed in the CAM treatmentcentre of the oncology hospital rather than the oncologist,as the oncologist referred the request directly to the CAMpractitioner.These seven cases represented a small portion ofthe patients treated with CAM in their centre; however, dueto time constraints, not all the cases were summarized andsubmitted. Steps II and III did not yield any additional cases.

5. Discussion

Considering the widespread use of CAM by pediatric cancerpatients, we anticipated that our Pediatric Best Case Serieswould reveal cases that had not been identified toNCI. In stepI of this study, however, only two of more than 200 COG sitescontributed valid cases. This approach had limited successin identifying pediatric best cases, as these cases were fewin number and generally only related to improved qualityof life. Since the majority of pediatric oncologists may notknow about their patients’ CAM use, we designed steps IIand III to overcome this limitation, as the point of contactwith patients then became CAM providers, not oncologists.Unfortunately, no further cases were identified, suggestingthat either pediatric best cases do not exist or the approachesused in this study were unable to identify them.

The limited response to our study may have been dueto various methodological factors. In step I, we had limitedresponse from pediatric oncologists. We believe their lack ofresponse may have been multifactorial: (i) time constraints(they are potentially too busy to participate in a study such

Evidence-Based Complementary and Alternative Medicine 3

Table 1: Pediatric Best Case Series: step I.

Age at diagnosis;gender Diagnosis CAM treatment details Overall outcome

12 years; F High grade osteosarcomaof right distal femur

TCM acupuncture and Vaccaria seed patch treatments forpain and narcotic wean

Improved quality oflife

3 years; M Burkitt’s lymphomaTCM acupuncture, acupressure, Vaccaria seed patches, andherbal therapy (out-patient) for pain, anxiety, poorcirculation, and feeding issues


14 months; F Acute lymphoblastleukemia

TCM acupressure, massage, and Vaccaria seed patches forimproving pain, appetite, insomnia


5 years; M NeuroblastomaTCM acupuncture, Vaccaria seed patches, moxibustion, andherbal therapy for pain, anxiety, appetite, fatigue, insomnia,and neurological deficits


4 years; M Neurofibromatosis type 2TCM acupuncture, acupressure, Vaccaria seed patches, andherbal therapy for severe, incapacitating headache, nausea,vomiting, and pain


11 years; M Acute lymphoblastleukemia with lymphoma

TCM acupuncture, acupressure, Vaccaria patches, andmassage to assist successful wean off ventilator, sedation,assist in rehabilitation, anxiety, fatigue, and weakness, poorappetite


15 years; F Acute myeloid leukemia

TCM acupuncture, acupressure, seed patch, and massage forpain, anxiety, neuropathic pain, shortness of breath,tolerance, nausea, vomiting, poor appetite, insomnia, anddepression


15 years; M Metastatic fibrolamellarhepatocellular carcinoma

Multiple nonconventional treatments including coffeeenemas and enzyme therapies

Temporary remission(6 months)

NR; NR Brain tumor Larch arabinogalactan for tolerance to narcotics Did not have theexpected cytopenias

as this); (ii) lack of oncologist awareness of pediatric CAMuse; and (iii) lack of willingness to believe that CAM mightbe beneficial for their patient population.While our approachwas far less resource intensive than that used by NCI andinvolved oncologists to ensure data quality regarding verifi-cation of diagnosis and disease course, potential best casesmay have been underestimated. A lack of communicationbetween pediatric oncologists and their patients about patientCAM use exists [7, 9, 12]. Even when such use is discussed, itis possible that pediatric oncologists did not consider theirpatient’s unexpected positive treatment results could be dueto CAM, preferring attribution to chance or use of conven-tional therapies. Some pediatric oncologists responded to ourinquiry in a very negative fashion, stating that they did notthink CAM use has any potential for beneficial effect. Shouldthis attitude be conveyed to their patients, it would likelyhinder meaningful dialogue as patients would not discloseif they feel their decision to use CAM therapies will bequestioned.

To overcome the issues faced in steps I, II, and III of ourstudy, we focused on CAM providers to initiate the reportingprocess. However, in order tomaintain data quality regardingverification of diagnosis and disease course, we asked thatthe pediatric oncologist participates in completing the casereport form. Potential limitations of this approach includethe apathy voiced by some CAM providers regarding therelevance of research to their practice. Data from a surveyof CAM practitioners’ conducted in Canada demonstrated

that only 66% of chiropractors, 72% of naturopaths, and 51%of osteopaths felt that their practice benefited from advancesin pediatric research [13]. Research is an onerous process,and it is unclear how many CAM providers are researchusers or feel comfortable with evidence-informed practice.Moreover, CAMprovidersmay have wished to avoid scrutinyby pediatric oncologists or our research team, anticipatingthat their therapies may be assessed in a potentially prejudi-cial manner that discounted their effectiveness. Some CAMproviders may have also simply wished to protect proprietaryprofessional practices and therefore refrained from reportingbest cases. Due to these limitations, we cannot determine ifpediatric best cases in association with CAM use are elusiveversus nonexistent.

Several programs to identify best or exceptional cases inoncology have been initiated. A brief summary is found inTable 2. The greatest differences between programs consistof how cases are obtained and what criteria are used todefine a “best case”. Based on our experience and the findingsfrom other initiatives, we suggest a hybrid model that offersthe combined strengths of the different programs: (i) thedefinition of “best cases” to be expanded based on outcomeschosen by patients, not only researchers or oncologists; thisapproach would support the inclusion of subjective andobjective assessments of therapeutic effect (e.g., survival andquality of life, not only tumour regression); (ii) patientswho use CAM concurrently with conventional medical treat-ment be eligible for study, as this is more reflective of real


Table 2: Best case programs—oncology cases.

Program/patientlocation/-scope/age/time frame

Primary goal How best cases aresubmitted/obtained

How best cases areevaluated

Criteria of a bestcase Program strengths

Studies

Care, Edmonton;North America;pediatric; 2007/2008

To identify andprioritize CAMtherapies that deservefurther evaluationand promotepartnerships that cansuccessfully enablethis goal.

Step IActive: email todirectors of all NorthAmerican COG sites(i) by oncologists.Step IIActive: advertised viaCAM researchnetworks(ii) by CAM providers.Step IIIActive: advertised viaCAM networks,associations, andtraining institutes(iii) by CAM providers.

Step IQualitative, descriptivesummaries.Step IIStudy coordinators,review the number andnature of reports, andcompare to phase I.Step IIIStudy coordinators,review number andnature of reports, andcompare to steps I andII.

Best Case toinclude: tumorregression,prolonged survival,and markedlyimproved qualityof life.

Active solicitation;broad definition ofbest case; inclusionof multiplereporting/IDsystems.

NCCAM, NIH,Bethesda; 2clinics-Freeport,Bahamas (immuno-augmentation therapy(IAT), and New York,NY (naltrexone); ageNR; 2001 [14]

Study used todetermine if sufficientevidence is present torecommend furtherstudy.

Active: visit to sites(i) by CAM providers.

Patient records wereobtained after receivingconsents; patients wereinterviewed bytelephone and screenedbased on the set criteria.

As for NCI(i) Documentationof diagnosis.(ii) Evaluation ofproper antitumorendpoint.(iii) Absence ofconcurrenttreatments.

Active solicitation.

Ulrik Dige, Denmark;Denmark; ages NR;dates NR [15]

Study conducted toexplore exceptionalcancer patients forfurther knowledgeabout CAM.

Active: media coverage(i) by patients.

As analysis of thecases;Dige conductedqualitative interviewsand a thoroughevaluation of medicalhospital records.

Well documentedimprovement ortotal remissionwithoutconventionaltreatment.


Johanna Hok:Stockholm, Sweden;Sweden; all ages;2004-2005[16]

Aim of the thesis toexplore perspectiveson CAM use amongindividuals withcancer in connectionto reportedexceptional sicknesstrajectories.

Active: media coverage(i) by patients.

Patient interviewsconducted along withevaluation of CAMreports using manifestcontent analysis andprincipal componentanalysis.

Cases were framedexceptional by theindividualsreporting the case.

Active solicitation;broad definition ofbest case.

Programs

National CancerInstitute (NCI),Bethesda;United States; all ages;1991–current[10, 11]

To identify CAMapproaches for cancerwhich warrantNCI-initiatedprospective research.

Passive:(i) by CAM provider.

Relevant medicalrecords documents,pathologic slides, andmedical imaging studiesreviewed by a Best-CaseSeries Review Team (1-2physicians and 1-2oncology nurses).

(i) Definitivediagnosis.(ii) Documenteddisease response.(iii) Absence ofconfounders.(iv) Documentedtreatment history.

Expert review ofcases.

NAFKAM, Norway;Scandinavia; all ages;up to 2002–08/2010[10, 17]

To develop a registryto facilitate researchon patients who haveexceptional diseasecourses/best andworse cases.

Passive:(i) by patient or byCAM provider.

Reviewed by NAFKAM’smedical doctor toclassify and assess casehistory.

(i) Experience ofunusual treatmentresults after the useof CAM.(ii) Confirmeddiagnosis beforestarting CAMtreatments.

Broad definition ofbest case.

Evidence-Based Complementary and Alternative Medicine 5

Table 2: Continued.

Program/patientlocation/-scope/age/time frame

Primary goal How best cases aresubmitted/obtained

How best cases areevaluated

Criteria of a bestcase Program strengths

UCMO, Germany;Klinikum Nuernberg;ages NR; 1989–current[10, 18]

To decide whetherpurportedtumor-specificefficacy of a CAMwarrants furtherinvestigation.

Active: contact of CAMprovided by UCMO.

Reviewed bycoordinating M.D. andinternal team ofoncologists, radiologists,and pathologists.

As for NCI. Active solicitation.

Hufeland Klinik Study,Germany; HufelandKlinik, BadMergentheim,Germany; all ages;1998/1999[19]

Patients evaluated tohelp identifytreatments thatwarranted furtherstudy.

Active:(i) by head practitionerselected cases forreview.

Reviewers eliminatedcases that did not fulfillbest case criteria basedon their summaries.

(i) Welldocumenteddiagnosis.(ii) Evidence ofcancer whenstarting CAM.(iii)Unconventionaltreatment receivedaccording to CAMpractitioner’sregime.(iv) Absence ofconcurrenttherapies.


world practice and is therefore valuable, albeit confoundeddata.

Our approach would be hypothesis generating, nothypothesis proving, and similar remarkable outcomes shouldbe spontaneously reported in association with the same inter-vention; this could justify further study; (iii) collaborationbetween programs would promote communication and ide-ally result in standardization of criteria and methods as wellas enhanced results; (iv) evaluating the potential to contactpatients directly through patient centered organizations suchas Canadian and US Cancer Societies; and (v) inclusion ofthe oncologist in the reporting process ensures data integritywith regards to diagnosis and expected course/prognosis andis far less exhaustive and resource intensive than the approachadopted by NCI. We would encourage the use of a mixedmethods approach that includes qualitative interviews withCAM practitioners and oncologists in order to better under-stand the research field and to develop better hypotheses andmethods to identify best cases in the future.

Due to heterogeneity of reported results as well asmissingresults in the original reports, we are unable to compareoutcomes of the various programs in terms of cases identifiedand classified as best cases. It is hoped that standardization ofmethods will allow for data comparison and combination infuture best case reports.

6. Conclusion

CAM use is extremely common amongst oncology patients,including children and youth. Despite multiple initiativesthat try to identify the positive effects of CAM use, veryfew best cases have been identified thus far. Our study has

evaluated the strengths and limitations of three differentapproaches to identify pediatric best cases. Since our greatestyield came frompediatric integrative oncology centers, whereCAM is included in patient treatment plans, we have initiateddiscussionswithNorthAmerican pediatric integrative oncol-ogy centers, as identified through the Society for IntegrativeOncology (SIO) andCOGCAMSpecial Interest Group, to setup a collaborative Pediatric Best Case Series. Our hope is toidentify these elusive cases and thereby generate hypothesesto support research that may benefit children with cancer.

Conflict of Interests

The authors have no conflict of interests relevant to this paperto disclose.

Funding

This work was founded by Lotte and John Hecht MemorialFoundation; the Canadian Interdisciplinary Network forComplementary and Alternative Medicine Research (IN-CAM); AHFMR summer studentships; SV salary supportfrom AIHS

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Research Article CAM and Pediatric Oncology: Where Are All ...downloads.hindawi.com/journals/ecam/2013/632351.pdf · and investigate exceptional cases or best cases in cancer patients